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Electronic ureteronephroscopory - NMPA Registration 粤械注准20242061019

Access comprehensive regulatory information for Electronic ureteronephroscopory in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242061019 and owned by Sonoscape MEDICAL Corp.. The device was approved on July 31, 2024.

This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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Class II
粤械注准20242061019
Electronic ureteronephroscopory
电子输尿管肾盂内窥镜
NMPA Registration Number: 粤械注准20242061019
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Pricing
Intended Use
English

It is used in medical institutions in conjunction with image processing devices manufactured by this manufacturer for imaging in the observation, diagnosis, and treatment of the urethra, bladder, ureter, and renal pelvis. Not to be used with high-frequency accessories.

中文

在医疗机构中与本制造商生产的图像处理装置配合使用,用于尿道、膀胱、输尿管、肾盂的观察、诊断和治疗中成像。不可与高频配件配合使用。

Device Classification
Device Class
Class II
Model Specifications
EUC-110S、EUC-X20S
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242061019
Approval Date
July 31, 2024
Expiry Date
July 30, 2029
Registrant
Name
Sonoscape MEDICAL Corp.
深圳开立生物医疗科技股份有限公司
Province/Region
Guangdong
广东
Address
Shenzhen Software Park (Phase 2), Building 12, 201, 202, No. 1, Keji Middle Road, High-tech Middle District, Maling Community, Yuehai Street, Nanshan District, Shenzhen
深圳市南山区粤海街道麻岭社区高新中区科技中2路1号深圳软件园(2期)12栋201、202
Production Facility
Production Address
深圳市光明区光明街道东周社区光明高新区东片区双明大道南侧二号路以西开立医疗大厦
Structure and Composition
English

The product consists of an electronic ureteral pelvic endoscope and accessories, including a clamp valve (VB-102CY) and a clamp perfusion joint (VBI-102CY).

中文

该产品由电子输尿管肾盂内窥镜及附件组成,附件包括钳道阀(VB-102CY)、钳道灌流接头(VBI-102CY)。

Additional Information
Appendix
产品技术要求